Valneva Provides Update on Recommendations for Use of IXCHIQ® in the United Kingdom
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that following a review of the benefits and risks of the Company’s single-dose chikungunya vaccine, IXCHIQ®, the United Kingdom’s (UK) Commission on Human Medicines (CHM) has updated its recommendations for use of the vaccine.
The updated Prescribing Information (PI) will reflect these recommendations, which now include a restriction for individuals over 60 years of age, for people with specified health conditions, as well as timing of vaccination prior to travel. For further details please refer to this link.
The MHRA confirmed that the benefit–risk profile of IXCHIQ® remains favorable for individuals aged 18 to 59 years who are at risk of chikungunya infection and do not have the contraindicated underlying medical conditions.
The update follows MHRA’s temporary suspension on the use of IXCHIQ® in older individuals, which was based on reports of serious adverse events (SAEs), mainly in elderly people with significant underlying medical conditions during an outbreak vaccination campaign on the French island of La Reunion.
Valneva is committed to upholding the highest safety standards and will continue monitoring post marketing safety data of IXCHIQ® and work in a collaborative way with all relevant authorities to potentially further update recommendations and restrictions of use, if justified.
Contact
Laetitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com
Joshua Drumm, Ph.D.
VP Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com